Assured regular strength acetaminophen capsule, gelatin coated

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Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • do not give this product to children for the pain of arthritis unless directed by a doctor

Otc - ask doctor section

Ask a doctor before use if the user hasliver disease

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if the user istaking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

adults and children 12 years and over
  • take 2 softgels every 4 to 6 hours while symptoms last
  • do not take more than 10 softgels in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children 6-11 years
  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor

Other information

  • store between 20-25C (68-77F)

Inactive ingredients

FD&C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

Call 1-888-333-9792

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DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Ingredients and appearance - Product information

Assured regular strength acetaminophen capsule, gelatin coated- Acetaminophen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68210-0012
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Fd&c red no. 40 ( UNII: WZB9127XOA)
Gelatin, unspecified ( UNII: 2G86QN327L)
Glycerin ( UNII: PDC6A3C0OX)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone k30 ( UNII: U725QWY32X)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color RED Score 1
Shape CAPSULE (OBLONG) Size 21 mm
Imprint Code 800

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part343 USA

Labeler - SPIRIT PHARMACEUTICALS LLC( 179621011)

Establishment

Name ID/FEI Business Operations
SPIRIT PHARMACEUTICALS LLC 179621011 MANUFACTURE( 68210-0012)

Principal display panel - 10 softgel bottle carton

ASSURED

COMPARE TOACTIVE INGREDIENT IN
TYLENOL ®REGULAR STRENGTH*

REGULAR STRENGTH

Acetaminophen

  • Acetaminophen 325 mg
    Pain Reliever / Fever Reducer

Actual Size

10 softgels